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Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument

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ClinicalTrials.gov Identifier: NCT04525651
Recruitment Status : Recruiting
First Posted : August 25, 2020
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

Brief Summary:
The investigators design a randomized, control study to evaluate the therapeutic effect of digital acupuncture instrument in cervical spondylotic radiculopathy patients using the following outcomes: the Visual analogue scale(VAS), neck disability index scale (NDI) and short form 36-item questionnaire (SF-36).

Condition or disease Intervention/treatment Phase
Cervical Spondylosis Device: Digital Acupuncture Manipulation Therapeutic Instrument Other: Manual Acupuncture Other: Sham Acupuncture Not Applicable

Detailed Description:
Based on the digital acupuncture manipulation therapeutic instrument developed in the previous stage, the acupuncture manipulation acquisition system is used to compare and analyze the analog waves output by the experts' acupuncture manipulation and the manipulative therapeutic apparatus in the system data analysis module, in order to verify the consistency of bioelectric signals of different reinforcing and reducing manipulation of acupuncture and experts' manipulation. The biocompatibility of shock wave was detected by Massachusetts General Hospital Needle sensation scale ((Massachusetts General Hospital Acupuncture Sensation Scale, MASS)). The visual analogue pain score ((Visual analogue scale, VAS)), neck disability index scale ((Neck Disability Index,NDI) and short form 36-item questionnaire (SF-36) were used to evaluate the clinical efficacy and safety of the instrument in the treatment of cervical pain in cervical Spondylotic radiculopathy, and the appropriate syndrome type of the scheme was studied.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Digital Acupuncture Instrument Group
The needles will be stimulated manually to achieve de qi (a compositional sensation including soreness, numbness, distention and heaviness) and then paired electrodes from the digital acupuncture instrument will be attached to the needle handles and another two adjunct acupoints by the research assistant. The electric current will be increased until the needles begin to vibrate slightly.
Device: Digital Acupuncture Manipulation Therapeutic Instrument
The device is based on the characteristics of traditional acupuncture manipulation of Shanghai School of Traditional Chinese Medicine, and absorbs the information of the techniques of famous experts, modulates the stimulation waveform of the electroacupuncture device by modulating the signal, and realizes the digitization of acupuncture technique information.

Active Comparator: Manual Acupuncture Group
Patients in the MA group will undergo similar procedures as the EA group except that no current will be output from the instrument.
Other: Manual Acupuncture
Manual acupuncture to acheive de qi.

Sham Comparator: Sham Acupuncture Group
Patients in the SA group will receive non-invasive acupuncture to avoid de qi.
Other: Sham Acupuncture
Sham acupuncture to avoid de qi.




Primary Outcome Measures :
  1. Visual Analogue scale(VAS) [ Time Frame: Change from baseline VAS at 4weeks ]
    A graphic scale that helps a patient to quantify pain, depression, and other subjective and otherwise unmeasurable states or conditions.

  2. Visual Analogue scale(VAS) [ Time Frame: Change from baseline VAS at 8weeks ]
    A graphic scale that helps a patient to quantify pain, depression, and other subjective and otherwise unmeasurable states or conditions.


Secondary Outcome Measures :
  1. Neck Disability Index(NDI) [ Time Frame: Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8) ]
    A scale that helps a patient to quantify neck disability.

  2. short form 36-item questionnaire, SF-36 [ Time Frame: Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8) ]
    a set of 36 questions abstracted from the much longer set of several hundred used in household interview surveys of the U.S. National Health Survey. The SF36 questions are a convenient abbreviation, used for screening purposes to assess the physical function, social function, role limitation, mental health, energy, vitality, pain, and subjective perception of health status. They have been tested and found to be valid and reliable.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Neck pain with the diagnosis of cervical spondylotic radiculopathy;
  2. Aged between 18-70 years;
  3. Have not participated in any drug clinical trials within the last month;
  4. Voluntarily joining this study with informed consents

Exclusion Criteria:

  1. A history of cervical spine trauma or have received cervical spine surgery;
  2. Accompanied by obvious dizziness and spinal cord compression symptoms or imaging findings of spinal cord compression;
  3. Cervical spondylosis in urgent need of surgery;
  4. Pregnant women and lactating women;
  5. A serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition
  6. Anticoagulant treatments such as warfarin or heparin use of pacemakers or receiving acupuncture in the past 2 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04525651


Contacts
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Contact: Jian Pei, Doctor 00862164385700 ext 3534 longhuaacup@aliyun.com

Locations
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China, Shanghai
LongHua Hospital Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jian Pei, Doctor    00862164385700 ext 3534    jianpei99@hotmail.com   
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Investigators
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Study Chair: Jian Pei, Doctor Shanghai University of Traditional Chinese Medicine
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Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT04525651    
Other Study ID Numbers: lhzj20200810
First Posted: August 25, 2020    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai University of Traditional Chinese Medicine:
digital acupuncture manipulation therapeutic instrument
cervical spondylosis
Additional relevant MeSH terms:
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Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases